U.S. Food and Drug Administration | Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 2 @US_FDA | Uploaded 2 months ago | Updated 1 hour ago
The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.
Timestamps
00:05 – Policy Accomplishments
15:33 – Policy Documents
28:34 – GDUFA III Suitability Petitions
40:14 – Recommended Supplemental In formation
49:48 – Overview of the FDA Product-Specific Guidance (PSG) Program
01:11:48 – Q&A Discussion Panel
Speakers | Panelists:
Martha Nguyen
Director
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA
Tina Kiang, PhD
Director
Division of Regulations and Guidance (DRGS)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Arlene Figueroa, JD
Regulatory Counsel
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD | CDER | FDA
Rosanne Pagaduan, PharmD
Supervisory General Health Scientist
Division of Filing Review (DFR)
Office of Regulatory Operations (ORO)
OGD | CDER | FDA
Joe Kotsybar, PharmD
Regulatory Health Project Manager
Office of Research and Standards (ORS)
OGD | CDER | FDA
Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff
Office of Quality Assurance (OQA)
OPQ | CDER | FDA
Jouhayna Saliba, PharmD
CAPT, United States Public Health Service (USPHS)
Team Leader
Drug Shortages Staff (DSS)
Office of the Center Director (OCD)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.
Timestamps
00:05 – Policy Accomplishments
15:33 – Policy Documents
28:34 – GDUFA III Suitability Petitions
40:14 – Recommended Supplemental In formation
49:48 – Overview of the FDA Product-Specific Guidance (PSG) Program
01:11:48 – Q&A Discussion Panel
Speakers | Panelists:
Martha Nguyen
Director
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA
Tina Kiang, PhD
Director
Division of Regulations and Guidance (DRGS)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Arlene Figueroa, JD
Regulatory Counsel
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD | CDER | FDA
Rosanne Pagaduan, PharmD
Supervisory General Health Scientist
Division of Filing Review (DFR)
Office of Regulatory Operations (ORO)
OGD | CDER | FDA
Joe Kotsybar, PharmD
Regulatory Health Project Manager
Office of Research and Standards (ORS)
OGD | CDER | FDA
Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff
Office of Quality Assurance (OQA)
OPQ | CDER | FDA
Jouhayna Saliba, PharmD
CAPT, United States Public Health Service (USPHS)
Team Leader
Drug Shortages Staff (DSS)
Office of the Center Director (OCD)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
